Start or STop Anticoagulants Randomised Trial (SoSTART) After Spontaneous Intracranial Haemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 67
- 主要终点
- Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial)
研究概览
简要总结
Primary research question: For adults surviving spontaneous (non-traumatic) symptomatic intracranial haemorrhage with persistent/paroxysmal atrial fibrillation/flutter (AF), does starting full treatment dose oral anticoagulation (OAC) result in a beneficial net reduction of all serious vascular events compared with not starting OAC?
Trial design: Investigator-led, multicentre, randomised, open, assessor-masked, parallel group, clinical trial of investigational medicinal product (CTIMP) prescribing strategies. Investigators plan for a pilot phase, followed by a safety phase.
详细描述
Bleeding within the skull, also known as brain haemorrhage, affects 3 million people in the world each year.
One in five people who survive brain haemorrhage have an irregular heart rhythm called 'atrial fibrillation', which puts them at risk of stroke and other blood clots.
Blood-thinning medicines, known as 'anticoagulant' drugs, are used in everyday clinical practice to protect people with atrial fibrillation from developing blood clots. However, these drugs also increase the risk of bleeding and are usually stopped when the brain haemorrhage occurs.
But when patients recover from brain haemorrhage, they and their doctors are often uncertain about whether to start or stop these drugs to prevent further clots occurring, or whether to avoid them in case they increase the risk of brain haemorrhage happening again.
Investigators want to find out whether starting or not starting an anticoagulant drugs is better for those patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
PROBE design
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥18 years
- •Symptomatic intracranial haemorrhage (i.e. intracerebral haemorrhage, non-aneurysmal subarachnoid haemorrhage,intraventricular haemorrhage, or subduralhaemorrhage)
- •Not attributable to a known underlying intracranial aneurysm, arteriovenous malformation, cerebral cavernous malformation, dural arteriovenous fistula, intracranial venous thrombosis
- •Not attributable to known head injury, based on:
- •a history from the patient/witness of spontaneous symptom onset without preceding head trauma (head trauma occurring after symptom onset is permissible)
- •brain imaging appearances consistent with spontaneous intracranial haemorrhage (which may be accompanied by the brain/bone/soft tissue appearances of trauma occurring subsequently)
- •Atrial fibrillation/flutter (persistent or paroxysmal) with a CHA2DS2-VASc score ≥2
- •If included in the brain magnetic resonance imaging (MRI) sub-study, the scan must be done after symptomatic intracranial haemorrhage and before randomisation
排除标准
- •Symptomatic intracranial haemorrhage within the last 24 hours (when the risk of haemorrhage expansion/growth is greatest)
- •Symptomatic intracranial haemorrhage is exclusively due to trauma or haemorrhagic transformation of ischaemic stroke
- •Prosthetic mechanical heart valve or severe (haemodynamically significant) native valve disease
- •Left atrial appendage occlusion for prevention of systemic embolism in AF done in the past, or intended to be performed
- •Intention to start antiplatelet drug(s) if randomised to start full dose OAC
- •Intention to start OAC or parenteral anticoagulation
- •Intention to implement the allocated treatment strategy for <1 year
- •Patient or their doctor is certain about whether to start or avoid full dose OAC
- •Brain imaging that first diagnosed the intracranial haemorrhage is not available
- •Patient is not registered with a general practitioner
- •Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception
- •Patient and carer unable to understand spoken or written English
- •Contraindications to any of the IMPs, other than recent intracranial haemorrhage
- •Contraindication to MRI (brain MRI sub-study)
- •Life expectancy less than one year
- •Previously randomised in SoSTART
研究组 & 干预措施
Start oral anticoagulant (OAC)
If the patient is randomized in this arm, an oral anticoagulant:
- Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban or
- Direct thrombin inhibitor: Dabigatran or
- Vitamin K antagonists: Acenocoumarol or Phenindione or Warfarin chosen by the patient's physician before the randomisation, will be prescribed long-term (≥1 year) to the patient.
干预措施: Apixaban (Drug)
Start oral anticoagulant (OAC)
If the patient is randomized in this arm, an oral anticoagulant:
- Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban or
- Direct thrombin inhibitor: Dabigatran or
- Vitamin K antagonists: Acenocoumarol or Phenindione or Warfarin chosen by the patient's physician before the randomisation, will be prescribed long-term (≥1 year) to the patient.
干预措施: Rivaroxaban (Drug)
Start oral anticoagulant (OAC)
If the patient is randomized in this arm, an oral anticoagulant:
- Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban or
- Direct thrombin inhibitor: Dabigatran or
- Vitamin K antagonists: Acenocoumarol or Phenindione or Warfarin chosen by the patient's physician before the randomisation, will be prescribed long-term (≥1 year) to the patient.
干预措施: Edoxaban (Drug)
Start oral anticoagulant (OAC)
If the patient is randomized in this arm, an oral anticoagulant:
- Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban or
- Direct thrombin inhibitor: Dabigatran or
- Vitamin K antagonists: Acenocoumarol or Phenindione or Warfarin chosen by the patient's physician before the randomisation, will be prescribed long-term (≥1 year) to the patient.
干预措施: Dabigatran (Drug)
Start oral anticoagulant (OAC)
If the patient is randomized in this arm, an oral anticoagulant:
- Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban or
- Direct thrombin inhibitor: Dabigatran or
- Vitamin K antagonists: Acenocoumarol or Phenindione or Warfarin chosen by the patient's physician before the randomisation, will be prescribed long-term (≥1 year) to the patient.
干预措施: Acenocoumarol (Drug)
Start oral anticoagulant (OAC)
If the patient is randomized in this arm, an oral anticoagulant:
- Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban or
- Direct thrombin inhibitor: Dabigatran or
- Vitamin K antagonists: Acenocoumarol or Phenindione or Warfarin chosen by the patient's physician before the randomisation, will be prescribed long-term (≥1 year) to the patient.
干预措施: Phenindione (Drug)
Start oral anticoagulant (OAC)
If the patient is randomized in this arm, an oral anticoagulant:
- Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban or
- Direct thrombin inhibitor: Dabigatran or
- Vitamin K antagonists: Acenocoumarol or Phenindione or Warfarin chosen by the patient's physician before the randomisation, will be prescribed long-term (≥1 year) to the patient.
干预措施: Warfarin (Drug)
结局指标
主要结局
Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial)
时间窗: 1 year after randomisation
\~60 hospital sites will recruit at least 190 participants to determine whether the risk of recurrent symptomatic intracranial haemorrhage is sufficiently low (non-inferior) to justify a definitive trial.
The number of participants recruited per site per month (in the pilot phase of the trial)
时间窗: 1 year after trial initiation
The rate of recruiting up to 60 participants to determine the feasibility of recruiting the target sample size in the main phase of the trial in an acceptable timescale.
次要结局
- The proportions of all eligible patients recorded on screening logs who are recruited, unsuitable, or decline to participate (in the pilot phase of the trial)(1 year after randomisation)